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    Why choose personalizedx for Vysis ALK?

    If your laboratory does not run molecular tests—such as the FISH-based (fluorescence in situ hybridization) Vysis ALK (Vysis ALK Break Apart FISH Probe Kit) to identify ALK gene rearrangements in patients with non-small cell lung cancer— PersonalizeDx can enable you to expand your service offerings. In this way, you can provide important information to oncologists that can aid in the selection of appropriate ALK-directed therapy.

    As a companion diagnostic test, Vysis ALK has these primary benefits:

    • The test accurately identifies ALK gene rearrangements in NSCLC patients.
    • Early FISH testing at diagnosis can assist physicians in determining appropriate ALK-directed therapy.
    • Vysis ALK is the only FDA-approved ALK companion diagnostic validated in XALKORI® (crizotinib) clinical trials. 

    The National Comprehensive Cancer Network (NCCN Guidelines™) recognizes the Vysis ALK Break Apart FISH Probe Kit (Vysis ALK) as a specifically designed method for diagnosing ALK-rearranged adenocarcinomas.1

    XALKORI® clinical trial information, Phase 21

    • 136 patients with locally advanced or metastatic ALK-positive NSCLC were treated with single-agent XALKORI® in a multi-center, 
      single-arm study.
    • ALK-positive NSCLC was identified using the Vysis ALK Break Apart FISH Probe Kit.
    • Patients received 250 mg of XALKORI® orally twice daily.
    • Primary endpoint: Objective Response Rate (ORR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
    • Median duration of treatment: 22 weeks.
    • Results: 1 complete and 67 partial responses for an ORR of 50% (95% CI: 42%, 59%). 79% of objective tumor responses were achieved during the first 8 weeks of treatment.

    Patients in this clinical trial were all ALK-positive and treated with XALKORI®, regardless of the phenotypic characteristics of sex, age, race, smoking status, or the histological classification of their NSCLC.

    Demographic and Disease Characteristics

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    Efficacy Results

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    a Response was assessed by the investigator
    b One patient was not evaluable for response
    c Preliminary estimate using Kaplan-Meier method.
    + Censored values
    CR = Complete Response
    PR = Partial Response

    In addition to Vysis ALK, PersonalizeDx offers a range of other lung cancer molecular tests.

    To Order Lung Cancer Tests
    For Specimen Collection and Shipping Instructions

    Intended Use

    The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib).
    The test is for prescription use only.

    Limitations of the Procedure

    • FOR IN VITRO DIAGNOSTIC USE ONLY.
    • Optimal performance of this test requires appropriate specimen handling, preparation, and storage as described in the instructions for use.
    • The Vysis ALK Break Apart FISH Probe Kit has been optimized only for identifying and quantifying rearrangements of the ALK gene from formalin-fixed, paraffin-embedded human NSCLC tissue specimens. The assay should be performed only on 10% neutral buffered formalin FFPE human lung cancer tissue. Other types of specimens or fixatives should not be used.
    • The performance of the Vysis ALK Break Apart FISH Probe Kit was established using the procedures provided in the assay package insert only. Modifications to the procedures may alter the performance of the assay.
    • The clinical interpretation of any test results should be evaluated within the context of the patient’s medical history and other diagnostic laboratory test results.
    • FISH assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate.
    • Technologists performing the FISH signal enumeration must be capable of visually distinguishing between the orange, green, and yellow signals.

    Caution

    United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; and use is restricted to, by, or on the order of a physician. 

    XALKORI® is a registered trademark of Pfizer Inc.

    FOR IN VITRO DIAGNOSTIC USE ONLY